Only fed study [Design Issues]

posted by roody – 2005-10-04 17:10 (5394 d 19:25 ago) – Posting: # 36
Views: 16,594

With reference to ANDA submission for US FDA, If the prescribing information says that the drug has to be taken under fed condition then whether it is necessary to conduct both fasted and fed studies? Can we only submit the fed study for immediate release formulation?

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